The following data is part of a premarket notification filed by Apollo Medical Imaging Technology Pty. Ltd. with the FDA for Automistar.
| Device ID | K192912 |
| 510k Number | K192912 |
| Device Name: | AutoMIStar |
| Classification | System, Image Processing, Radiological |
| Applicant | Apollo Medical Imaging Technology Pty. Ltd. Suite 611 365 Little Collins Street Melbourne, AU Vic 3000 |
| Contact | Qing Yang |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-10-15 |
| Decision Date | 2019-12-31 |
| Summary: | summary |